Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664739
• Other study ID #: V01-120A-301
• Status: Completed
• Phase: Phase 3
• Start date: December 5, 2018
• Est. completion date: March 23, 2020

Study information

• Verified date: March 2023
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel

Description:

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne

Recruitment information / eligibility

• Status: Completed
• Enrollment: 608
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

1. Male or female at least 9 years of age and older;

2. Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit);

3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS) assessment at the baseline visit;

4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;

5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;

6. Subjects with two or fewer facial nodules

Exclusion Criteria:

1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;

2. Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema;

3. Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive;

4. Subjects with a facial beard or mustache that could interfere with the study assessments;

5. Subjects with more than two (2) facial nodules;

6. Evidence or history of cosmetic-related acne

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• IDP-120 Gel
IDP-120 Gel, once-daily application
• IDp-120 Vehicle Gel
IDP-120 Vehicle Gel, once-daily application

Locations

Country	Name	City	State
Canada	Valeant Site 112	Markham	Ontario
Canada	Valeant Site 102	Waterloo	Ontario
Canada	Valeant Site 114	Waterloo	Ontario
Canada	Valeant Site 125	Waterloo	Ontario
Canada	Valeant Site 127	Waterloo	Ontario
United States	Valeant Site 109	Austin	Texas
United States	Valeant Site 120	Beverly Hills	California
United States	Valeant Site 113	Clearwater	Florida
United States	Valeant Site 128	Denver	Colorado
United States	Valeant Site 119	Detroit	Michigan
United States	Valeant Site 117	Encinitas	California
United States	Valeant Site 124	Evansville	Indiana
United States	Valeant Site 107	Fremont	California
United States	Valeant Site 108	High Point	North Carolina
United States	Valeant Site 121	Hot Springs	Arkansas
United States	Valeant Site 118	Largo	Maryland
United States	Valeant Site 111	Louisville	Kentucky
United States	Valeant Site 123	Mobile	Alabama
United States	Valeant Site 129	Needham	Massachusetts
United States	Valeant Site 126	New York	New York
United States	Valeant Site 110	Norfolk	Virginia
United States	Valeant Site 122	North Miami Beach	Florida
United States	Valeant Site 101	Oakbrook Terrace	Illinois
United States	Valeant Site 106	Oklahoma City	Oklahoma
United States	Valeant Site 130	Pflugerville	Texas
United States	Valeant Site 105	San Antonio	Texas
United States	Valeant Site 104	San Diego	California
United States	Valeant Site 116	Walla Walla	Washington
United States	Valeant Site 103	West Palm Beach	Florida
United States	Valeant Site 115	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change in Mean Lesion Counts at Week 12	For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.	Baseline to Week 12
Primary	Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"	Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.	Baseline to Week 12
Secondary	Percentage Change in Mean Lesion Counts at Week 12	For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.	Baseline to Week 12
Secondary	Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)	Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.	Baseline to Week 12
Secondary	Percentage Change in Mean Lesion Counts at Week 8	For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.	Baseline to Week 8
Secondary	Percentage Change in Mean Lesion Counts at Week 4	For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.	Baseline to Week 4